Balloon encapsulated catheter tip

ABSTRACT

This invention is generally related to catheters for insertion into a body cavity, duct or vessel, and more particularly to a tip or plug for a catheter. The catheter tip is constructed and arranged to form a seal on the end portion of the catheter tube, while a sleeve secured or formed integrally to the tip cooperates with the catheter tube to form a first balloon that encapsulates the tip of the catheter and a second balloon that positions the catheter within the body cavity, duct or vessel.

CROSS REFERENCE TO RELATED APPLICATIONS

In accordance with 37 C.F.R. 1.76, a claim of priority is included in anApplication Data Sheet filed concurrently herewith. Accordingly, thepresent invention claims priority as a continuation of U.S. patentapplication Ser. No. 12/912,349, filed Oct. 26, 2010, entitled “BALLOONENCAPSULATED CATHETER TIP”, which claims priority of U.S. ProvisionalApplication No. 61/254,950, filed on Oct. 26, 2009, entitled “BALLOONENCAPSULATED CATHETER TIP”. The contents of which the above referencedapplications are herein incorporated by reference. This application isalso related to U.S. Pat. No. 4,351,342 entitled, “BALLOON CATHETER”,filed on Sep. 28, 1982, and issued to Bruce E. Wiita and J. MichaelTeets, the contents of which are herein incorporated by reference.

FIELD OF THE INVENTION

This invention relates to medical devices, and more specifically to aballoon encapsulated catheter tip or plug that is constructed andarranged for insertion into a body cavity, duct or vessel.

BACKGROUND OF THE INVENTION

This invention is generally related to catheters for insertion into abody cavity, duct or vessel, and more particularly to a tip or plug fora catheter. The catheter tip is constructed and arranged to form a sealon the end portion of the catheter tube, while a sleeve secured orformed integrally to the tip cooperates with the catheter tube to form afirst balloon that encapsulates the tip of the catheter and a secondballoon that positions the catheter within the body cavity, duct orvessel. For a better understanding of this invention, it will bedescribed in connection with a urinary catheter, which is one area wherethis invention has commercial potential.

Urinary Catheters have been used for many years. A particularly wellknown urinary catheter is the Foley catheter. The Foley catheterincludes a flexible tube made of latex and/or silicone material and hastwo internal lumens extending substantially parallel along the length ofthe tube. A balloon is positioned near the distal end of the tube forholding the catheter in position within the bladder of a patient. Thecatheter is positioned within the patient and fluid is introducedthrough one of the lumens to inflate the balloon to retain the catheterin the desired position. A drainage port or eye is located at the distalend of the catheter to allow the urine to pass through one of the lumensof the catheter tube for urine drainage purposes. However, the Foleycatheter, like all other currently and commercially available catheters,suffers from the same or a similar drawback in that they have a tip thatextends beyond the balloon. This tip often bears or scrapes against theliner of the bladder causing trauma to the bladder lining and isassociated with numerous medical problems. A further problem relates tothe position of the drain port(s) causing patient discomfort when themucosal lining is drawn into the drain port(s). Some examples of themedical problems associated with the current catheter devices includediscomfort, spasms and bleeding, as well as more serious drawbacks suchas bacteria in the blood stream, e.g. Urosepsis and urinary tractinfections.

Therefore what is needed in the art is a catheter tip that includes afirst balloon positioned to encapsulate the tip of the catheter and asecond balloon to position the catheter within the urinary tract. Thefirst balloon should be constructed and arranged to cushion the cathetertip from traumatizing and irritating the internal wall of the cavity,duct or vessel. Moreover, the balloon should be connected to the tip soas to prevent the tip from moving relative to the balloon.

PRIOR ART

Numerous types of catheters are known in the prior art. For example,U.S. Pat. No. 4,022,216 discloses a urological catheter having at itsdistal portion a pair of balloons which are inflatable from the proximalend of the catheter. In the inflated position, the one of the balloonscompletely covers the distal tip of the catheter to serve as a cushionfor preventing damage to the patient's bladder, while the other balloonserves to anchor the catheter in sealing relation to the dischargepassage of the bladder. A drainage opening in the catheter wall isdisposed intermediate the balloons. While the '216 patent discloses dualballoons, the balloon which encloses the distal end is connected to thecatheter along the side of the catheter body. This connection allows thetip to move relative to the balloon and can easily cause top over andblockage of the drainage aperture.

U.S. Pat. No. 4,342,316 discloses a catheter comprising an elongatedshaft having an inflation lumen extending along the shaft, and adrainage lumen extending through the shaft. The catheter has a proximalend, a distal end, and a distal end portion. The catheter also has anelastic sleeve on the distal end portion of the catheter and opposedends. The sleeve is bonded to the distal end portion in spacedcircumferential zones adjacent the opposed ends of the sleeve and alonglongitudinal lines at least a substantial distance between the zones onopposed sides of the distal end portion. The catheter has an inflationopening beneath the sleeve communicating with the inflation lumen, andat least one drainage eye proximal the sleeve and communicating with thedrainage lumen. One of the major disadvantages of the '316 patent isthat the tip of the catheter is exposed and can damage any tissuestructure that the catheter may be inserted within.

U.S. Pat. No. 4,575,371 discloses a urinary catheter with a retentionmember in the form of an expandable balloon. The expandable balloon isarranged below the inlet opening and so designed that in its inflatedcondition a portion projects forward past the catheter tip at somedistance from the inlet opening. A shortcoming of the '371 patent,however, includes the fact that the drainage aperture is placed at thedistal end of the catheter, resulting in a greater tendency to have themucosal lining of the bladder being drawn into the drainage port when inuse. Moreover, only a single balloon is connected to the body of thecatheter and is connected in such a manner that the tip of the cathetercan move relative to the balloon.

U.S. Publication 2009/0221992 discloses a fluid drainage catheter. Thecatheter comprises a catheter tube having proximal and distal ends and acylindrical wall with a lumen extending generally from the proximal tothe distal end to permit the passage of fluid therethrough. The cathetertube is formed such that the proximal end has a closed tip for insertionof the catheter tube into a body cavity, and the distal end has anopening for the drainage of fluid from the body cavity through thecatheter tube. The cylindrical wall has an outer surface with at leastone defined external flow path extending generally in a longitudinaldirection from a point in proximity to the closed tip to a pointdistally thereof. A drainage eye is associated with the defined externalflow path and extends completely through the catheter tube from theouter surface to the lumen to permit fluid in the flow path to passthrough the drainage eye into the lumen. A drawback to the '992 catheteris that the tip is not completely covered increasing the risk of contactwith tissue structures, resulting in damage and leading to increasedrisk of infection.

SUMMARY OF THE INVENTION

The needs, disadvantages and limitations of the background art discussedabove are overcome by the present invention. The instant invention isgenerally related to catheters, and more specifically, the instantinvention provides a catheter assembly or catheter tip that includes afirst balloon constructed and arranged to encapsulate the tip of thecatheter to prevent the drawbacks of the prior art, and a second balloonto position the catheter within a body duct, cavity, or vessel. Thecatheter tip includes a cap having a stem portion and a sleeve portionsecured to or integrally formed with the cap. The tip and sleeve arepreferably constructed of resiliently flexible biocompatiblematerial(s). The cap portion of the tip is constructed and arranged tobe attached to the distal end of a catheter tube while the optional stemis inserted into the drain lumen of the catheter tube. The attachedsleeve portion is extended over the outer surface of the end portion ofthe catheter tube and is selectively attached to the outer surface ofthe catheter tube in a manner that forms a first balloon positioned toencircle the cap at the distal end of the tube, and at least one secondballoon positioned along the catheter tube to retain and/or position thecatheter within a body cavity, duct or vessel. The balloons areexpandable by admitting a preferably sterile fluid through one or morecontrol lumen(s) extending through the catheter tube. The control lumensextend along the catheter tube substantially parallel to the drainlumen. Each control lumen is preferably provided with at least oneaperture extending through the side wall of the catheter tube positionedin the area of one or more of the balloons to allow the fluid to enterthe balloon from the lumen. The tip and sleeve are both preferably madeof a biocompatible elastomeric material such as, but not limited to,natural rubber latex, synthetic rubber, plastic and silicone and may beprepared, as is known in the art, to include additives, suspensionsand/or coatings specially utilized in the process of fabricatingcatheter balloons or used to prevent sticking together in storage orenhance lubricity. In addition, the inner and/or outer surfaces of thesleeve may include thick and/or thin sections, ribs or portions to causethe balloon to inflate to a desired shape. The tip and sleeve may befabricated by any suitable process which may include but should not belimited to injection molding, dipping, vacuum forming, roto-molding,blow molding or suitable combination(s) thereof. In a most preferredembodiment, the sleeve is formed in an inside-out arrangement. Afterforming, the sleeve portion is preferably rolled, much like that of acondom. The tip is assembled to the catheter tube by inserting the stemportion of the plug into the central lumen of the catheter tube untilthe lower surface of the cap contacts the distal end of the cathetertube. Adhesive, solvents, fillers, radio frequency (RF) welding, laserwelding or suitable combinations thereof may be utilized to secure thetip to the tube and/or seal the distal end of the catheter tube. Thesleeve material may then be rolled over the outer surface of thecatheter tube. At least two spaced apart and circumferentially extendingbands of adhesive are positioned about the end portion of the cathetertube to secure the sleeve to the outer surface of the tube while formingthe two balloons. Varying the width of the adhesive bands or distancebetween the adhesive bands allows the size of the balloons to be varied.It should be noted that solvents, radio frequency (RF) welding, laserwelding or suitable combinations thereof may be utilized to secure thesleeve to the outer surface of the tube forming the two balloons. Itshould also be noted that the sleeve portion may be dipped into asolution that serves to expand the sleeve material before or afterattachment to the catheter tube, such as an alcohol-based fluid,benzene, ether or the like. This expansion may allow for the sleeve tobe easily rolled over the outer surface of the catheter tube, oralternatively, slid over the catheter tube, if left un-rolled. It shouldfurther be noted that the portion of the sleeve between the bands ofadhesive may be removed, or the second balloon may be formed from asecond sleeve of material without departing from the scope of theinvention.

When assembled, the balloons may be expanded by admitting a fluidthrough one or more of the control lumens which open into the area ofone or both of the balloons so that the sleeve material is expanded in aradial and/or axial direction so that the distal balloon extends beyondthe distal surface of the tip, and as a result, serves as a barrierbetween the tip and the lining of the bladder.

Thus, it is an object of this invention to provide a unique constructionfor a catheter tip.

It is another object of this invention to provide a tip for a catheterwherein the tip is constructed and arranged to form a balloon to preventthe distal end of the catheter from impinging against the inner wall ofa body duct, cavity or vessel.

It is yet another object of this invention to provide a tip for acatheter that includes an elongated sleeve secured thereto whichcooperates with the side wall of the catheter tube for forming at leastone balloon along the end portion of the catheter.

It is yet another object of this invention to provide a duct, cavity orvessel catheter that includes a protective balloon on the distal end ofthe catheter.

It is still yet another object of this invention to provide a catheterthat includes a first balloon to circumscribe the tip of the catheterand a second balloon to position the catheter within a body duct, cavityor vessel.

Still another object of this invention is to provide a urinary catheterhaving a first balloon to circumscribe the tip of the catheter and asecond balloon to position the catheter within the urinary tract.

Still yet another object of this invention is to provide a catheter ortip for a catheter having a balloon that, when inflated, extendsradially and axially beyond the distal end of the catheter.

Yet a further object of the invention is to provide a catheter balloonthat includes ribs or a combination of areas of different thicknesses toprovide a shape or direct the expansion of the balloon in a desireddirection or area.

Still another object of the invention is to provide a catheter balloonthat includes lobes or a combination of areas of different thicknessesto provide a shape or direct the expansion of the balloon in a desireddirection or area.

Still yet a further object of the invention is to provide a catheterballoon that includes a drain port positioned between two balloons toreduce or eliminate the tendency of the mucosal lining from being drawninto the drain port during use.

The foregoing and other features of the present invention will becomemore apparent from the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view of the catheter system in accordance withthe instant invention, illustrating the tip and sleeve as well as aportion of the catheter tube;

FIG. 1B is an exploded view of the catheter system in accordance withthe instant invention, illustrating the tip and an alternativeembodiment of the sleeve as well as a portion of the catheter tube;

FIG. 2A is a perspective view of one embodiment of the catheter systemin accordance with the instant invention;

FIG. 2B is a perspective view of one embodiment of the catheter systemin accordance with the instant invention, illustrating the regions ofthe catheter body which may contain varying thicknesses;

FIG. 3 is a perspective view of one embodiment of the instant inventionillustrating the balloons in an expanded condition;

FIG. 4 is a section view taken along lines 4-4 of FIG. 2A illustratingthe tip and sleeve assembled to the catheter tube as well as the lumensfor passing urine and fluid;

FIG. 5A is a section view taken along lines 5A-5A of FIG. 2A;

FIG. 5B is a section view taken along lines 5B-5B of FIG. 2B;

FIG. 6 is a section view taken along lines 6-6 of FIG. 3 illustratingthe balloons in an expanded condition;

FIG. 7 is a section view taken of one embodiment of the instantinvention similar to that of FIG. 4, illustrating an opening at thedistal most portion of the tip of the catheter system;

FIG. 8 is a section view taken of one embodiment of the instantinvention similar to that of FIG. 6, illustrating an opening at thedistal most portion of the tip of the catheter system;

FIG. 9 is an exploded view of an alternative embodiment of the cathetersystem in accordance with the instant invention, illustrating the tipand sleeve as well as a portion of the catheter tube;

FIG. 10 is a perspective view of an alternative embodiment of thecatheter system in accordance with the instant invention;

FIG. 11 is a perspective view of an alternative embodiment of theinstant invention illustrating the balloons in an expanded condition;

FIG. 12 is a section view taken along lines 12-12 of FIG. 10illustrating the tip and sleeve assembled to the catheter tube as wellas the lumens for passing urine and fluid;

FIG. 13 is a section view taken along lines 13-13 of FIG. 10;

FIG. 14 is a section view taken along lines 14-14 of FIG. 11illustrating the balloons in an expanded condition;

FIG. 15 is a perspective view of one embodiment of the instant inventionillustrating one rib longitudinally aligned on the distal most expandedballoon;

FIG. 16 is a perspective view of one embodiment of the instant inventionillustrating a plurality of ribs longitudinally aligned on the distalmost expanded balloon;

FIG. 17 is a perspective view of one embodiment of the instant inventionillustrating one rib longitudinally aligned on the proximal mostexpanded balloon;

FIG. 18 is a perspective view of one embodiment of the instant inventionillustrating a plurality of ribs longitudinally aligned on the proximalmost expanded balloon;

FIG. 19 is a perspective view of one embodiment of the instant inventionillustrating at least one balloon having one or more lobes;

FIG. 20 is a perspective view of the embodiment of the instant inventionshown in FIG. 19, illustrating one of the balloons in a misalignedposition;

FIG. 21 is a perspective view of an alternative embodiment of theinstant invention illustrating both balloons having one or more lobes atthe distal ends, proximal beds, or combinations thereof;

FIG. 22 is a perspective view of the alternative embodiment of theinstant invention shown in FIG. 21, illustrating one of the balloons ina misaligned position;

FIG. 23 is a perspective view of the catheter tip in accordance with theinstant invention, illustrated in the non-inflated state;

FIG. 24 is a perspective view of the catheter tip in accordance with theinstant invention, illustrated in the partially inflated state; and

FIG. 25 is a perspective view of the catheter tip in accordance with theinstant invention, illustrated in the fully inflated state.

DETAILED DESCRIPTION OF THE INVENTION

While this invention is being described in its preferred embodiment ashaving a definitive catheter, it should be understood that the catheteris a commercially available item and that the invention is appliedthereto and, as will be appreciated by one skilled in this technology,that the invention has utility for other types of catheters, some ofwhich are disclosed in U.S. Pat. No. 4,351,342, supra.

Referring to FIGS. 1-6, the instant invention provides a catheterassembly 100 or catheter tip 10 that includes a first balloon 13constructed and arranged to encapsulate the distal end 12 of thecatheter to prevent the drawbacks of the prior art, and a second balloon14 to position the catheter within a body duct, cavity, or vessel (notshown). The catheter tip 10 includes a cap 16 preferably having a stemportion 18 and a sleeve portion 20 secured to or integrally formed withthe cap. The tip 10 and sleeve 20 are preferably constructed ofresiliently flexible biocompatible material(s). The cap portion 16 ofthe tip 10 is constructed and arranged to be attached to the distal end12 of a catheter tube 24 while the optional stem 18 is inserted into thedrain lumen 26 of the catheter tube 24. The attached sleeve portion 20is extended over the outer surface 28 of the end portion of the cathetertube 24 and is selectively attached to the outer surface 28 of thecatheter tube 24 in a manner that forms a first balloon 13 positioned toencircle and extend beyond the cap 16 at the distal end of the tube, andat least one second balloon 14 positioned along the catheter tube 24 toretain and/or position the catheter 100 within a body cavity, duct orvessel.

FIG. 1A illustrates the sleeve portion 20 having a generally tubularshape with the unattached side having a diameter that is generally thesame as the end portion which attaches to the cap 16. The tubular shapeof the sleeve portion extends outwardly in a distal direction, restingabove the cap 16. As illustrated in FIG. 1B, the sleeve portion 20 mayalternatively be constructed such that the unattached portion has alarger diameter as compared to the attached end. In this manner, thebody of the sleeve portion 20 tapers as the sleeve body gets closer tothe cap 16. The balloons 13 and 14, see FIGS. 3, are expandable byadmitting a preferably sterile fluid through one or more controllumen(s) 30 extending through the catheter tube 24. The control lumen(s)30 extend along the catheter tube 24 substantially parallel to the drainlumen 26. Each control lumen 30 is preferably provided with at least oneaperture 32 extending through the side wall of the catheter tube 24. Theaperture 32 is preferably positioned in the area of one or more of theballoons 13 and 14 to allow the fluid to enter one or both balloons fromthe lumen. Check valves, or the like, (not shown), may be utilized tocontrol the flow of fluid into and/or out of the balloons. It should benoted that while the embodiment illustrated only shows one controllumen, multiple control lumens could be provided without departing fromthe scope of the invention. The tip 10 and sleeve 20 are both preferablymade of a biocompatible elastomeric material such as, but not limitedto, natural rubber latex, synthetic rubber, plastic, silicone, andplatinum cured silicone, and may be prepared, as is known in the art, toinclude additives, suspensions and/or coatings specially utilized in theprocess of fabricating catheters and/or catheter balloons or used toprevent sticking together in storage or enhance lubricity. In addition,the inner 40 and/or outer surfaces 42 of the sleeve 20 may include thicksections 44, thin sections 46, ribs 34 or portions to cause the balloons13 and 14 to inflate to a desired shape. Obviously, the thinner portionsof the balloon will afford less resistance to the pressure of theflowing water and hence, will expand more easily than the thickerportion. In a most preferred embodiment, the first balloon 13 isconstructed and arranged to expand in a linear as well as a radialrelationship to extend past the distal end 12 of the tip 10. The tip 10and sleeve 20 may be fabricated to be integral or separate by anysuitable process which may include but should not be limited toinjection molding, dipping, vacuum forming, roto-molding, blow moldingor suitable combination(s) thereof. In a most preferred embodiment, thesleeve 20 is formed in an inside-out arrangement. After forming, thesleeve portion 20 is preferably rolled, much like that of a condom. Thetip 10 is assembled to the catheter tube 24 by inserting the stemportion 18 of the tip into the drain lumen 26 of the catheter tube untilthe lower surface 36 of the cap 16 contacts the distal end 22 of thecatheter tube 24. Adhesive, solvents, fillers, radio frequency (RF)welding, laser welding or suitable combinations thereof may be utilizedto secure the tip to the tube and/or seal the distal end of the cathetertube. Alternatively, the stem portion 18 may contain a securing member(not illustrated) such as barbs, spikes, or the like, to secure the stemportion to the catheter tube. In a preferred embodiment, the distal endand/or the lower surface 36 is covered with an adhesive material therebyforming a circumferential seal. The sleeve portion 20 may then be rolledover the outer surface 28 of the catheter tube 24. At least two spacedapart and circumferentially extending bands of adhesive 38 arepositioned about the end portion of the catheter tube to secure thesleeve to the outer surface of the tube while forming the two balloons13 and 14. Varying the width of the adhesive bands 38 or distancebetween the adhesive bands allows the size of the balloons to be varied.At least one drain port 50 is preferably positioned between the twoballoons, i.e. proximal to balloon 13 and distal to balloon 14, toreduce or prevent the bladder lining from being drawn into the catheterduring use. One or more drain ports 250, see FIG. 10, 12, or 14, mayoptionally be positioned below balloon 214. It should be noted thatsolvents, radio frequency (RF) welding, laser welding or suitablecombinations thereof may be utilized to secure the sleeve to the outersurface of the tube forming the two balloons without departing from thescope of the invention. It should also be noted that the sleeve portionmay be dipped into a solution that serves to expand the sleeve materialbefore or after attachment to the catheter tube, such as analcohol-based fluid, benzene, ether or the like. This expansion mayallow for the sleeve portion 20 to be easily rolled over the outersurface of catheter tube, or alternatively, slid over the catheter tube,if left un-rolled. It should further be noted that the portion of thesleeve between the bands of adhesive may be removed or the secondballoon may be formed from a second sleeve of material without departingfrom the scope of the invention.

While each of the FIGS. 1-6 illustrate the cap having a closed end, thecatheter system or catheter tip may include an internal cavity 51 withinthe cap 16 and stem portion 18. The internal cavity 51 terminates in anopening 53 and provides fluid flow between the external environment andthe distal end 12 of the catheter system 100 or catheter tip 10 to itsproximal end 14, see FIGS. 7 and 8.

FIGS. 9-14 illustrates an alternative embodiment of the catheterassembly or catheter tip in accordance with the instant invention. Thecatheter assembly 200 or catheter tip 210 includes a first balloon 213constructed and arranged to encapsulate the distal end 212 of thecatheter to prevent injury to a body duct, cavity, or vessel, and asecond balloon 214 to position the catheter within the body duct,cavity, or vessel (not shown). The catheter tip 210 includes a cap 216preferably having a stem portion 218 and a sleeve portion 220 secured toor integrally formed with the cap 216. The tip 210 and sleeve 220 arepreferably constructed of resiliently flexible biocompatiblematerial(s). The cap portion 216 of the tip 210 is constructed andarranged to be attached to the distal end 212 of a catheter tube 224while the optional stem 218 is inserted into the drain lumen 226 of thecatheter tube 224.

The attached sleeve portion 220 is extended over the outer surface 228of the end portion of the catheter tube 224 and is selectively attachedto the outer surface 228 of the catheter tube 224 in a manner that formsa first balloon 213 positioned to encircle and extend beyond the cap 216at the distal end of the tube, and at least one second balloon 214positioned along the catheter tube 224 to retain and/or position thecatheter 200 within a body cavity, duct or vessel. The sleeve portion220 may have a generally tubular shape with the unattached side having adiameter that is generally the same as the end portion which attaches tothe cap 216. The tubular shape of the sleeve portion 220 extendsoutwardly in a distal direction, resting above the cap 216.

Alternatively, the sleeve portion 220 may be constructed such that theunattached portion has a larger diameter as compared to the attachedend. In this manner, the body of the sleeve portion 220 therefore tapersas the sleeve body gets closer the cap 216, similar to that illustratedin FIG. 1B. The balloons 213 and 214 are expandable by admitting apreferably sterile fluid through a plurality of control lumens 230A and230B extending through the catheter tube 24. The control lumens230A/230B extend along the catheter tube 224 substantially parallel tothe drain lumen 226. The control lumens 230A and 230B are preferablyprovided with at least one aperture 232 extending through the side wallof the catheter tube 224. The aperture 232 is preferably positioned inthe area of one or more of the balloons 213 and 214 to allow the fluidto enter one or both balloons from the lumen.

Check valves 233, 235, or the like, may be utilized to control the flowof fluid into and/or out of the balloons. It should be noted that whilethe embodiment illustrated shows control lumen 230A and 230B as lumensfor the purpose of inflation of the balloons, control lumens 230A or230B can be used to dispense, aspirate, or combinations thereof, fluidinto or out of the body duct, cavity, or vessel without departing fromthe scope of the invention. To accomplish such a task, the catheter tube224 may contain an additional aperture which provides fluidcommunication with the control lumen 230A and 230B and the externalenvironment, i.e. the body cavity. Additionally, valve 237 is utilizedto control the flow of fluid into and/or out of the main drainage lumen226. The tip 210 and sleeve 220 are both preferably made of abiocompatible elastomeric material such as, but not limited to, naturalrubber latex, synthetic rubber, plastic and silicone and may beprepared, as is known in the art, to include additives, suspensionsand/or coatings specially utilized in the process of fabricatingcatheters and/or catheter balloons or used to prevent sticking togetherin storage or enhance lubricity.

In addition, the inner 240 and/or outer surfaces 242 of the sleeve 220may include thick sections and/or thin sections, ribs, similar to thatillustrated and described previously, or portions to cause the balloons213 and 214 to inflate to a desired shape. Obviously, the thinnerportions of the balloon will afford less resistance to the pressure ofthe flowing water and hence, will expand more easily than the thickerportion. In a most preferred embodiment, the first balloon 213 isconstructed and arranged to expand in a linear as well as a radialrelationship to extend past the distal end 212 of the tip 210. The tip210 and sleeve 220 may be fabricated to be integral or separate by anysuitable process which may include but should not be limited toinjection molding, dipping, vacuum forming, roto-molding, blow moldingor suitable combination(s) thereof. In a most preferred embodiment, thesleeve 220 is formed in an inside-out arrangement.

After forming, the sleeve portion 220 is preferably rolled, much likethat of a condom. The tip 210 is assembled to the catheter tube 224 byinserting the stem portion 218 of the tip into the drain lumen 226 ofthe catheter tube until the lower surface 236 of the cap 216 contactsthe distal end 222 of the catheter tube 224. Adhesive, solvents,fillers, radio frequency (RF) welding, laser welding or suitablecombinations thereof may be utilized to secure the tip to the tubeand/or seal the distal end of the catheter tube. Alternatively, the stemportion 218 may contain a securing member (not illustrated) such asbarbs, spikes, or the like, to secure the stem portion to the cathetertube. The sleeve portion 220 may then be rolled over the outer surface228 of the catheter tube 224.

At least two spaced apart and circumferentially extending bands ofadhesive 238 are positioned about the end portion of the catheter tubeto secure the sleeve 220 to the outer surface of the tube while formingthe two balloons 213 and 214. Varying the width of the adhesive bands238 or distance between the adhesive bands allows the size of theballoons to be varied. At least one drain port 250 is preferablypositioned between the two balloons, i.e. proximal to balloon 13 anddistal to balloon 14, to reduce or prevent the bladder lining from beingdrawn into the catheter during use. One or more drain ports 250 mayoptionally be positioned below balloon 214. It should be noted thatsolvents, radio frequency (RF) welding, laser welding or suitablecombinations thereof may be utilized to secure the sleeve to the outersurface of the tube forming the two balloons without departing from thescope of the invention. It should also be noted that the sleeve portionmay be dipped into a solution that serves to expand the sleeve materialbefore or after attachment to the catheter tube, such as analcohol-based fluid, benzene, ether or the like. This expansion mayallow for the sleeve portion 220 to be easily rolled over the outersurface of catheter tube, or alternatively, slid over the catheter tube,if left un-rolled. It should further be noted that the portion of thesleeve between the bands of adhesive may be removed or the secondballoon may be formed from a second sleeve of material without departingfrom the scope of the invention.

Optionally, the catheter system 200 may contain a support member whichis positioned between balloons 213 and 214, see FIG. 14. The supportmember 252, which may be, for example, a sleeve member or support walls,minimizes the effects of lateral motion on balloons 213 and 214 andprevents balloon 213 from tipping over onto balloon 214.

Each of the balloons 13 (213) and 14 (214) may be designed to inflate toany size necessary. In a preferred embodiment, the balloon size of oneballoon, for example balloon 13 is designed to be smaller when inflatedthan the balloon size of the other balloon, i.e. balloon 14. Thedifference between sizes of the two balloons can vary depending in theuse of the catheter. In an illustrative example, the difference betweenballoon 13 and balloon 14 could be in the range of approximately 20% to80%, based on the actual size of the fully inflated balloons or based onthe injection volume of each of the balloons. The sizing of balloon 13,for example, can be designed such that a maximum size of the balloon isnot too large so as to be susceptible to bending. Since the preferredembodiment described a double balloon with drainage aperture forproviding drainage of fluid from a bladder, should the balloon 13 be toolarge and bend, the catheter may become inefficient as a result of theformation of a kink. Formation of such a kink results in sealing of thedrainage aperture and blocks the balloon's inflation lumen. In additionto preventing fluid flow, the ability of the balloon 13 to deflate willbe limited or completely prevented. Each of the balloons 13 and 14 mayadditionally be made of materials having deferent thickness and/ordurometer values. Such differing thickness may result in inflation ofthe balloons at differing rates. In a preferred embodiment, thethickness of each of the balloons can be designed such that balloon 14inflates before the balloon 13. Inflation in this manner providesenhanced safety measures. For example, in use as a urinary catheter,ensuring that the proximal balloon (balloon 14) inflates before thedistal balloon (balloon 13) ensures that no balloon will be inflatedwithin the urethra.

FIGS. 15-22 illustrate various embodiments of balloons 13 and 14 of thecatheter system 100 or catheter tip 10 constructed with a plurality ofareas of varying thicknesses to create ribs, lobes and variously shapedballoons. While such figures are illustrative of the catheter system 100and catheter tip 10, each of the embodiments described are applicable tothe catheter system 200 and catheter tip 210 or any system/tip inaccordance with the instant invention. The balloon 13, the balloon 14,or both balloon 13 and 14 may contain ribs 34 or lobes 52. While each ofthe balloons may contain any number of ribs 34 or lobes 52, a preferredembodiment provides for at least 3 ribs 34 or lobes 52 longitudinallyalong the balloon 13. The rib 34 or lobe 52 begins at the most distalend and terminates at approximately the half-way point the balloon. Theformation of the ribs or lobes functions to add strength to the balloon,allow residual fluid, i.e. urine, to run off the tip of the balloon, andwhen inflated provide an area of recess.

In addition to, or instead of, balloon 14 may also contain ribs 34 orlobes 52. While such ribs and lobes may be aligned radially, a preferredembodiment includes the ribs and lobes being aligned longitudinally, andextending from the distal end. Use of ribs and lobes along balloon 14allows the entire balloon or portions of it, to inflate more thanstandard balloons, thus bringing balloon 13 and 14 closer together whenboth are fully or partially inflated, thereby minimizing tissueaspiration into the drainage apertures and preventing the balloon 13from bending over, or top over and forming kinks. FIG. 19 shows anillustrative example of the catheter system 100 having a plurality oflobes 52 formed at the top end of balloon 14. Should balloon 13 becamemisaligned, see FIG. 20, the lobes 52 prevent the balloon from completetop over and allow for the balloon 13 to return to its originalposition. FIG. 21 illustrates use of a plurality of lobes formed on bothof the balloons 13 and 14. As illustrated, the lobes 52 can bepositioned along the distal end (top edge) 52A, the proximal end (bottomedge) 52B, or combinations thereof, see balloon 14. The lobes formed onboth balloons 13 and 14 may be aligned in substantially the same planwhen each of the balloons are inflated and are in the proper alignment,see FIG. 21. Should the balloon 13 become misaligned and tip, see FIG.22, the lobes associated with balloon 14 contact the lobes of balloon13, thereby limiting the degree of top over, preventing kinking, andblocking of the drainage aperture.

In a preferred embodiment, the cap 16 is constructed and arranged toprovide traversal between a resting stage and an elongated state;preferably through the type of material it is constructed of and throughcontrol of its thickness and/or resistance to change shapes. FIG. 23illustrates the cap 16 in its resting state. In this configuration, theballoons have not been inflated. As the balloons receive an inflationfluid and inflate, see FIG. 24, the shape of the cap 16 traverses fromits resting state to an inflation state. In this second configuration,the cap 16 elongates, see FIG. 25, as the balloons take in fluid andfully inflate. The degree of elongation can vary depending on thematerial used, the durometer of the balloons and/or cap, or the lengthpulled. In a preferred embodiment, the cap 16 is constructed to elongatea distance in the range of approximately 10%-200% relative the length ofthe cap at its resting state. As the inflation fluid is removed and theballoons deflate, cap 16 retains its original starting shape.

Although this invention has been shown and described with respect todetailed embodiments thereof, it will be appreciated and understood bythose skilled in the art that various changes in form and detail thereofmay be made without departing from the spirit and scope of the disclosedinvention.

What is claimed is:
 1. A catheter assembly having an encapsulatedcatheter tip for encapsulating a distal end of the catheter therebyminimizing the risk of infection comprising: a catheter body having adistal end, a proximal end, and a plurality of lumens extendinggenerally from said distal end to said proximal end, said plurality oflumens including at least one drainage lumen in fluid communication witha drainage port for providing fluid flow within said drainage lumen, andat least one control lumen, said control lumen being in fluidcommunication with a sleeve member for providing inflation of saidsleeve thereby forming one or more inflatable areas; a catheter tiphaving a cap comprising a distal end and a proximal end, said tipconstructed and arranged to cooperate with one of said plurality oflumens, said catheter tip having a sleeve member which contains a firstend integrally formed to the said distal of said catheter tip and asecond end secured to a plurality of positions along said catheter body,thereby forming a first balloon constructed and arranged to provide abarrier between said catheter tip and a body duct, tissue cavity orvessel, and a second balloon constructed and arranged to position saidcatheter within said body duct, tissue cavity or vessel; wherebyinflation of said first balloon results in encapsulation of said distalend of said catheter thereby preventing damage to said body duct, tissuecavity or vessel, and inflation of said second balloon provides securingof said catheter to said body duct, tissue cavity, or vessel.
 2. Thecatheter assembly according to claim 1 wherein said plurality of lumensincludes at least one lumen which is fluidly connected to the externalenvironment for dispensing fluids from said lumen to the externalenvironment, aspirating fluids from the external environment to saidlumen, or combinations thereof.
 3. The catheter assembly according toclaim 1 wherein said cap further includes a stem portion, said stemportion constructed and arranged to engage said drainage lumen, whereinsaid engagement secures said cap to said catheter body.
 4. The catheterassembly according to claim 3 wherein said stem portion contains one ormore securing members.
 5. The catheter assembly according to claim 4wherein said securing members are barbs.
 6. The catheter assemblyaccording to claim 3 wherein said cap is secured to said catheter bodythrough adhesives, solvents, fillers, radio frequency (RF) welding,laser welding, or combinations thereof.
 7. The catheter assemblyaccording to claim 2 wherein at least one drain port is positionedproximally to said first balloon and distally to said second balloon,said positioning minimizing or preventing the lining of said body duct,tissue cavity, or vessel from being drawn into the catheter during use.8. The catheter assembly according to claim 2 wherein the size of eachsaid balloon is varied.
 9. The catheter assembly according to claim 8wherein said first balloon is larger than said second balloon.
 10. Thecatheter assembly according to claim 8 wherein said first balloon issmaller than said second balloon.
 11. The catheter assembly according toclaim 1 wherein the outer surface of said sleeve includes one or morethick sections, one or more thin sections, or combinations therefore,for providing varied regions along said balloon which have variedresistance to inflation.
 12. The catheter assembly according to claim 1wherein said first balloon, said second balloon, or combinations thereofcontain one or more ribs.
 13. The catheter assembly according to claim12 wherein said ribs are arranged circumferentially along said balloons.14. The catheter assembly according to claim 12 wherein said ribs arearranged longitudinally along said balloons.
 15. The catheter assemblyaccording to claim 13 wherein the outer surface, the inner surface, orcombinations thereof, of said first balloon has a greater resistance toinflation than the outer surface, the inner surface, or combinationsthereof, of said second balloon, whereby said second balloon inflatesprior to the inflation of said first balloon.
 16. The catheter assemblyaccording to claim 11 wherein said first balloon, said second balloon,or combinations thereof contain one or more lobes.
 17. The catheterassembly according to claim 16 wherein each of said balloons contain oneor more lobes, said one or more lobes of said first balloon and said oneor more lobes of said second balloon are aligned in such a manner so asshould said first balloon and said second balloon become misaligned, aproper spacing between said misaligned balloons is maintained such thatsaid first balloon does not completely block fluid flow from theexternal environment to within said drainage lumen, thereby preventingsaid drainage port from being obstructed.
 18. The catheter assemblyaccording claim 6 wherein said at least one balloon extends radially andaxially beyond said distal end of the catheter.
 19. The catheterassembly according to claim 6 wherein said cap is made from abiocompatible elastomeric material which when in cooperative engagementwith said catheter tube can elongate as said one or more balloonstraverses between a first non-inflated position and a second inflatedposition.